Comparison of efficacy & safety of two frontline induction regimens in newly diagnosed multiple myeloma: A randomized, assessor-blinded pilot study - CARBO

AIIMS Rishikesh0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年11月21日

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•Patients of newly diagnosed symptomatic multiple myeloma (as per IMWG38 diagnostic criteria), of age >= 18 years & any gender, who are willing to participate in the study.
•Patients with measurable disease as defined by >= 1 of the following criteria, obtained within 1 month of randomization:
•o > 1 g/dL monoclonal protein on serum protein electrophoresis (SPEP)
•o > 200 mg/24 hours of monoclonal protein on a 24 hour urine protein electrophoresis (UPEP)
•oSerum involved free light chain (SFLC) >= 100 mg/L and abnormal serum immunoglobulin kappa to lambda free light chain ratio ( < 0.26 or > 1.65)
•Life expectancy >= 6 months.
•Written informed consent.
•Patients with a history of prior malignancy who have been treated with curative intent and do not require active therapy.
•If there is no residual toxicity related to prior radiation given to symptomatic lesions, patient can be included in the study.

•Pregnant women
•Nursing women
•Patients who have received more than one cycle (4 weeks or less) and 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic multiple myeloma.
•Patients with uncontrolled hypertension or diabetes, New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF), unstable angina, myocardial infarction within previous 6 months, Grade 3 conduction abnormalities unless patient has a pacemaker, history of torsade de pointes, QTc prolongation ( >450 msec), left ventricular ejection fraction <40%, uncontrolled arrhythmia, sick sinus syndrome, or any medical condition that would compromise with compliance with protocol and therapy.
•Patients with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM).
•Patients with peripheral neuropathy ( grade 3-4 or lower grade with pain) by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.37
•Patients having severe, uncontrolled illness.
•Plasma cell leukemia ( absolute plasma cell count > 2 x 109/L or 20 percent of peripheral white blood cells).

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